Long-term Efficacy and Safety of Aclidinium Bromide/Formoterol Fumarate Fixed-Dose Combination

Summary

The objective is to provide data supporting the use of LAS40464 as an efficacious and safe maintenance bronchodilator treatment of patients with Chronic Obstructive Pulmonary Disease (COPD).

Timeline

Start

2011-10

Primary completion

2013-01

Completion

2013-01

Outcome

Met primary endpoint

registry Aclidinium/Formoterol 400/12 μg vs Aclidinium 400 μg; p <0.0001; Least Squares Mean Difference 0.125 (95% CI 0.090 to 0.160) NCT01462942 ↗

registry Aclidinium/Formoterol 400/12 μg vs Formoterol 12 μg; p <0.0001; Least Squares Mean Difference 0.085 (95% CI 0.051 to 0.119) NCT01462942 ↗

Publications

• Singh D, D'Urzo AD, Donohue JF, Kerwin EM, Molins E, Chuecos F, Ribera A, Jarreta D. An Evaluation Of Single And Dual Long-Acting Bronchodilator Therapy As Effective Interventions In Maintenance Therapy-Naive Patients With COPD. Int J Chron Obstruct Pulmon Dis. 2019 Dec 6;14:2835-2848. doi: 10.2147/COPD.S217710. eCollection 2019.
• Singh D, D'Urzo AD, Chuecos F, Munoz A, Garcia Gil E. Reduction in clinically important deterioration in chronic obstructive pulmonary disease with aclidinium/formoterol. Respir Res. 2017 May 30;18(1):106. doi: 10.1186/s12931-017-0583-0.
• Bateman ED, Chapman KR, Singh D, D'Urzo AD, Molins E, Leselbaum A, Gil EG. Aclidinium bromide and formoterol fumarate as a fixed-dose combination in COPD: pooled analysis of symptoms and exacerbations from two six-month, multicentre, randomised studies (ACLIFORM and AUGMENT). Respir Res. 2015 Aug 2;16(1):92. doi: 10.1186/s12931-015-0250-2.
• Singh D, Jones PW, Bateman ED, Korn S, Serra C, Molins E, Caracta C, Gil EG, Leselbaum A. Efficacy and safety of aclidinium bromide/formoterol fumarate fixed-dose combinations compared with individual components and placebo in patients with COPD (ACLIFORM-COPD): a multicentre, randomised study. BMC Pulm Med. 2014 Nov 18;14:178. doi: 10.1186/1471-2466-14-178.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aclidinium	Unknown	400 ug	Other
Comparator	Formoterol	Other / unclassified	6 ug	Other
Comparator	Formoterol	Other / unclassified	12 ug	Other

Indications